Rationalize Your Labeling Approach to Prepare for the EU MDRs

The new European Union regulations for medical devices (EU MDRs) will have major implications for the labeling operations of every medical device manufacturer that trades in the EU. The regulations have far-reaching impact, and they are why labeling has recently become a mission-critical business system for medical device companies. Failure to produce accurate, MDR-compliant labeling may result in organizations that are no longer able to distribute their products in Europe, causing products to be unnecessarily stockpiled or even resulting in costly and embarrassing product recalls. The needs for new symbology and additional warning and precautions statements as well as the requirement to carry details of a licensed EU representative are likely to result in labeling congestion. In some cases, this may require a major redesign of label layouts and possibly accelerate the move from linear to 2D bar codes to capture more data in a machine-readable format. Some aspects of the new symbology indicating that the product is a medical device are still to be finalized. Given that potentially thousands of labels will be impacted, now would be a good time to take the opportunity to rationalize the global labeling estate. Organization-Wide Impact Making wholesale changes to labeling and artwork assets in timescales dictated by the management board or in this case, regulatory bodies, can be a huge undertaking. It’s likely that many products will have been in existence over...
Source: MDDI - Category: Medical Devices Authors: Tags: Labeling Source Type: news